{"id":43674,"date":"2024-09-13T11:06:35","date_gmt":"2024-09-13T09:06:35","guid":{"rendered":"https:\/\/pgxperts.com\/?p=43674"},"modified":"2026-01-08T10:25:30","modified_gmt":"2026-01-08T09:25:30","slug":"en-iso-13485-certification","status":"publish","type":"post","link":"https:\/\/pgxperts.com\/en\/news\/en-iso-13485-certification\/","title":{"rendered":"PGXperts GmbH receives ISO EN 13485 certification"},"content":{"rendered":"

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Back<\/a><\/p>\n

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PGXperts receives certification of its quality management system according to EN ISO 13485:2016 <\/strong><\/h1>\n

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PGXperts has successfully received certification of its quality management system according to EN ISO 13485:2016 as software manufacturer of medical devices for the provision of information for the verification of pharmacogenetic and pharmacological interactions.<\/strong><\/p>\n

[\/et_pb_text][et_pb_text _builder_version=”4.27.0″ _module_preset=”default” text_font_size=”18px” text_font_size_tablet=”17px” text_font_size_phone=”16px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}”]The MedTech company thus meets the highest regulatory requirements for a quality management system for the production of software as a medical device. The scope of the certification includes the design and development, manufacture, installation and distribution of the PGXperts System.[\/et_pb_text][et_pb_text _builder_version=”4.27.0″ _module_preset=”default” text_font_size=”18px” text_font_size_tablet=”17px” text_font_size_phone=”16px” text_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}”]<\/p>\n

\n

\u201eQuality and safety are the foundation of our daily work. We are very proud to have achieved this special milestone of ISO certification just eight months after our spin-off. This underscores our commitment to the highest standards to increase patient safety and enable personalized medicine.” <\/em><\/p>\n

– Herna Mu\u00f1oz-Galeano, Founder and Managing Director of PGXperts GmbH<\/em><\/p>\n<\/blockquote>\n

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PGXperts – Personalized Medication using Pharmacogenetics<\/strong><\/h2>\n

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PGXperts enables personalization of current and future medication with the aim of increasing drug therapy safety. The PGXperts system provides physicians with evidence-based knowledge about the interaction between drugs and a patient’s genetic characteristics. With information on specific interaction risks (drug-gene, drug-drug, drug-food), the medication can be checked individually for a patient. PGXperts interprets genetic characteristics and provides the treating physician with the results in the form of clinical consequences and specific measures. <\/p>\n

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Quality management system according to EN ISO 13485:2016<\/strong><\/h2>\n

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The EN ISO 13485:2016 standard specifies the regulatory requirements for a quality management system for manufacturers and suppliers of medical devices. The aim of the ISO standard is the manufacture of safe and reliable medical devices in the EU. <\/p>\n

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PGXperts has successfully received certification of its quality management system according to EN ISO 13485:2016 as software manufacturer of medical devices for the provision of information for the verification of pharmacogenetic and pharmacological interactions.<\/p>\n","protected":false},"author":12,"featured_media":62936,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[63],"tags":[],"class_list":["post-43674","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pressemitteilung"],"yoast_head":"\nPGXperts GmbH receives ISO EN 13485 certification - PGXperts<\/title>\n<meta name=\"description\" content=\"F\u00fcrth, 13.09.2024 - PGXperts GmbH has successfully obtained certification of its quality management system in accordance with EN ISO 13485:2016.\" \/>\n<meta name=\"robots\" content=\"noindex, nofollow\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"PGXperts GmbH receives ISO EN 13485 certification - 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